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Meg Bohne, Consumers Union
1 Comment
Consumers Union’s Approach to Improving Drug Safety Surveillance is Misguided [view article]
Consumers Union is a strong advocate for EHRs. But, as you made clear, implementing a nationwide system on linked electronic health systems will take time. It may be the most efficient and accurate way to report adverse events, but until the technology is utilized by a majority of doctors offices AEs will go largely untracked. The plain fact is many doctors don’t report them. An Institute of Medicine report found that in 2004, only 21,500 of the 423,000 adverse event reports that year came from doctors and patients.The brother of a colleague of mine is a case in point. He had a very serious reaction to drug recently. His doctor did tests and pulled him off the drug immediately. He asked his doctor if he would report this to the FDA. The doctor said that he would be more mindful of this side effect when prescribing this type of drug (a statin to lower cholesterol) in the future, but he just didn’t have the time to report it to the FDA. The patient (my colleague’s brother) reported it to the FDA’ s Medwatch system.
Until there is a system-wide surveillance program for AEs – and full doctor compliance with reporting requirements – it is critical for consumers to have a way to report their experiences, especially if their doctors won’t. The Medwatch system was created to field reports from doctors as well as consumers – unfortunately, most consumers don’t know about this resource.
Congress already mandates that all printed drug ads contain the Medwatch 1-800 number and web address. Consumers Union’s petition makes the logical case that this information also be included in TV ads, which will reach millions more consumers.
Mar 20 05:17 PM